Device recall
Z-3259-2026: New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level…
FDA device recall · Class II · New York Embroidery Studio, Inc.
Key facts
| Recall number (Z-number) | Z-3259-2026 |
|---|---|
| Recall event | 99760 |
| Product | New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case. |
| Product code | OEA |
| Recalling firm | New York Embroidery Studio, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3007088677 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database